CEO SUMMARY: Advanced Pathology Associates, a 15-member private pathology group practice, had the distinction of generating data for the clinical study that Philips submitted to the Food and Drug Administration for review of its whole slide imaging system. Following the FDA’s decision to clear this system for sale earlier this month, and informed by their
Tag: molecular laboratory
CEO SUMMARY: Pathologists and clinical lab managers interested in following the advances in use of whole human genome sequencing for clinical purposes should follow the money. Within weeks of obtaining FDA clearance for its MiSeqDx system and reagents, Illumina had inked major agreements with Quest Diagnostics Incorporated and Laboratory Corporation of America. Both national lab
EVERY DAY, ACROSS THE GLOBE, labs perform testing using Sanger sequencing and other fundamental techniques of proteomics and genomics pioneered and developed by Frederick Sanger, who died last month at the age of 95.
Sanger is considered one of the giants in biochemistry. He was one of only three people awarded two Nobel prizes in science.
CEO Summary: Pre-authorization of expensive genetic and molecular tests is a threat to local clinical laboratories and pathology groups if payers exclude them from provider networks in favor of labs which bid the lowest prices. But one major healthcare corporation believes there is now an opportunity for clinical labs and pathology groups to deliver added
Point-of-care testing (POCT) continues to gather momentum and grow at much faster rates than routine clinical laboratory testing. That’s the finding of analysts at Frost & Sullivan. In the United States, POCT product sales totaled $2.1 billion in 2009. Frost & Sullivan predicts that POCT sales will top $3.9 billion by 2016. It says the
CEO SUMMARY: In presenting this list of macro trends for clinical laboratories, several themes are in play. They range from a continued emphasis on improving lab operations to the need to acquire and deploy sophisticated information technology. During the next few years, the long-predicted retirement of Baby Boomers will kick in. That will aggravate the
CEO SUMMARY: Laboratories that offer molecular assays continue to see strong growth in four areas: oncology, hematopathology, infectious diseases, and personalized medicine. Further, a new generation of molecular testing systems and analyzers is coming to market which will make it easier for even smaller community hospital laboratories to establish and perform molecular tests that are
CEO SUMMARY: In the same way that the Human Genome Project was disrupted by the entry of C. Craig Venter and Perkin-Elmer in what was then a 15-year, $3 billion project, now Complete Genetics of Mountain View, California, is disrupting the race to the $1,000 human genome sequence. Developments in this field are moving at
CEO SUMMARY: Growing numbers of laboratories are taking steps to reengineer work flow, evaluate automation solutions, and improve the operational performance of their laboratory. This is fueling a demand for laboratory consulting services and Ascendium Consulting is this newest healthcare and lab consulting company in this marketplace. It became operational on January 1, 2008, as
CEO SUMMARY: In the 15 years it has operated a molecular diagnostics testing program, Beaumont Reference Laboratory (BRL) has learned important lessons on how to evaluate which specific molecular assays are ready for clinical introduction. It has also learned effective ways to anticipate the clinical and financial success of such assays. Part II of this